Lead - Clinical Study Management
Smith+Nephew is seeking a remote leader (US/Canada) to oversee complex, global clinical research studies from initiation through close-out. This pivotal role manages stakeholder engagement, study documentation, vendor oversight, and ensures compliance with ICH-GCP and ISO 14155. The role offers a competitive base salary of $123,500–$184,775 USD/CAD, comprehensive benefits, flexible PTO, 401K, parental leave, and strong wellbeing programs, reflecting Smith+Nephew’s commitment to inclusion and work-life balance.
Qualified candidates will have a Bachelor’s degree or higher in a scientific or clinical field, extensive clinical study management experience (BS + 6 years, MS + 3 years, or PhD + 1 year), GCP certification, and in-depth regulatory knowledge. Key skills include leadership, project management, strong decision-making, and excellent communication in English.
Smith+Nephew is committed to diversity, equity, and inclusion, and provides a range of professional development and wellness resources. Employees can work flexibly in a collaborative, mission-driven environment making a tangible impact on patient lives.
Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Join us as a Lead – Clinical Study Management and play a pivotal role in shaping the future of clinical research. This is your opportunity to lead complex, global studies that make a real difference to patients’ lives—all while working remotely from anywhere in the US or Canada.
What will you be doing?
Lead and oversee all activities for large, complex Smith+Nephew-sponsored clinical studies from start-up through close-out
Act as the primary point of contact for internal and external stakeholders, ensuring strong collaboration across cross-functional teams
Develop and maintain essential study documents including protocols, monitoring plans, and consents
Manage vendor qualifications and maintain oversight throughout the study lifecycle
Support site identification and engagement, including investigator meetings and study communications
Ensure compliance with ICH-GCP, ISO 14155, and regional regulatory requirements
Monitor study quality through training, compliance reviews, and corrective actions
Oversee study budgets, timelines, and data integrity using established systems and processes
What will you need to be successful?
Bachelor’s degree or higher in a scientific, clinical, or related field
GCP certification and in-depth knowledge of regulatory requirements
Extensive experience in clinical study management: BS + 6 years, MS + 3 years, or PhD + 1 year
Strong leadership, project management, and decision-making skills with the ability to handle complex projects independently
Excellent communication and relationship-building skills in English
You Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
Flexibility: Hybrid Work Model (For most professional roles)
Training: Hands-On, Team-Customized, Mentorship
Extra Perks: Discounts on fitness clubs, travel and more!
The anticipated base compensation range for this position is $123,500-$184,775 USD annually or $123,500-$185,250 CAD. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, parental leave, and generous PTO, paid company holidays annually and 8 hours of Volunteer time and a variety of wellness offerings such as EAP.
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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